For a long time, pharmacy and medicine in every society used drugs that produce effects on pain, mood, thought, feeling, behavior, and psychological personality. These drugs are represented by opioids, barbiturates, hypnotics, central nervous system stimulants, central nervous system depressants, psychostimulants, alcohols, cannabinoids, and catecholamines. In present medicine, one class of these drugs has become the standard invention for the management of Attention-Deficit Disorder, that is, the central nervous system stimulants. While this invention presents central nervous system drugs in greater detail, it is understood the invention is generic and embraces drugs broadly administered using the dosage forms and the method of the invention.
The benefits perceived by parents, teachers, physicians, psychologists, social workers, and clinicians are dramatic for central nervous system drugs, and this has resulted in the widespread and acceptable use of central nervous system medication to treat Attention-Deficit Disorder. In 1994, the latest period for collecting data, it was observed that about two percent of the school-aged female population and about six percent of the school-aged male population, for a total of about two million patients, were administered the medication for Attention-Deficit Disorder.
Prior to the advent of this invention, the dosage form and the method for administering a drug, for example, a central nervous system acting drug, consisted in using a standard pharmaceutical dosage form. For example, one prior art dosage form and method for administering a drug, such as the central nervous system drug methylphenidate, consists in using an immediate release tablet containing the drug. This immediate release form delivers the drug by instant dumping of the drug and this produces uneven blood levels characterized by peaks and valleys. For an immediate release form containing methylphenidate which is characterized by a rapid onset and a short half-life to produce the intended therapy, multiple doses are needed each day that can result in swings in behavior and in attention as the medication loses its therapeutic effect. This dosage form does not provide the needed therapy over an extended time.
Another prior art dosage form for dispensing a drug is the sustained-release dosage form. A drug dispensed from a prior art sustained-release dosage form may ascend initially but not over the entire dosing interval, and it actually may decline over time. That is, these sustained-release dosage forms dispense a drug in a nonascending profile over time, as they do not provide a continuously increasing release rate per hour throughout the extended dosing period. This dosage form, additionally, may not provide the required duration of therapy and the appropriate blood pattern. For drugs that act on the central nervous system, like methylphenidate, dispensed from a sustained-release nonascending dosage form, the patient often develops an acute tolerance to the drug manifested by a shortened duration and a decrease in the intensity of the therapeutic effect needed for acceptable therapy. The prior sustained-release delivery is also devoid of means that compensate for its shortcomings inherent therein.
The above presentation teaches that a critical need exists for a novel dosage form and for a novel method for administering a drug that overcomes the shortcomings known to the prior art. This long-felt need exists for a dosage form and for a method for (1) administering the drug at a sustained-increasing rate that simultaneously reduces or eliminates the frequency of daily dosing; for (2) a dosage form and a method for administering the drug in a sustained-compensating dose to substantially compensate for acute tolerance to the drug thereby maintaining a preselected clinical response; for (3) a dosage form that administers the drug in a sustained-ascending profile clinically indicated for the management of Attention-Deficit Disorders; and, for (4) a dosage form and a method for administering the drug initially and in a sustained-ascending profile throughout the entire school day.